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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 2-Feb-12 BY LAUREN UZDIENSKI, FEBRUARY 2, 2012

Earnings
Exactech pre-announced 4Q:11 sales of $53.1 million, up 3% over the year-ago period. Analysts had forecast 4Q:11 revenues of $53.7 million. The company expects knee sales to decrease by 2% for the quarter; extremities sales to increase by 29%; hip sales to increase by 13%; biologic & spine sales to decrease by 21%; and "other" revenue to decline by 4%.

Kensey Nash reported F2Q:12 sales and royalties of $23.0 million, up 32% over the year-ago period and missing estimates by $1.3 million. Orthopedic sales increased by 53% after adjusting for the impact of the Norian acquisition. Adjusted EPS was $0.51, compared to $0.38 in F2Q:11, and beat estimates by $0.05.

RTI Biologics reported 4Q:11 revenues of $42.9 million, up 2% over the year-ago period and beating estimates by $1.7 million. The company attributed performance to "the strength of the sports medicine and [bone graft substitutes/general orthopedic] businesses. Net income for the quarter was $2.4 million, or $0.04 per share, which compares to net income of $2.8, or $0.05 per share, in 4Q:10. Analysts had forecast EPS of $0.03.

Smith & Nephew reported 4Q:11 revenues of $1.1 billion, up 3% over the year-ago period and missing estimates by $26.0 million. Orthopedics revenue was flat at $586.0 million; recon was flat, with knee up by 2% and hip down by 2%. Trauma declined by 2%. Clinical Therapies increased by 8%. Endoscopy sales increased by 7%. Growth rates exclude the effects of currency. Adjusted EPS was $0.22, in line with the prior year and beating estimates by a penny.

Funding
CartiHeal raised $5.0 million in venture funding from two U.S.-Israeli venture capital firms, Accelmed and Access Medical Ventures. The financing will be used to prepare its first product launch early 2013 in Europe. The company is developing proprietary, off-the-shelf and cell-free cartilage regeneration technology.

Checkpoint Surgical completed a $1.7 million Series B investment round led by the NDI Healthcare Fund in December 2011. The company also secured non-dilutive funding of over $1.3 million, including a $1.1 million Innovation Ohio loan and a $245,000 federal grant. The company manufactures the CHECKPOINT Stimulator/Locator, a hand-held, intraoperative nerve and muscle stimulator that helps surgeons to locate, identify and evaluate nerves during surgery to facilitate nerve preservation and repair.

ConforMIS raised $89.0 million in a Series E round of funding, with additional funds beyond this amount committed upon meeting certain milestones. The company will use the funds to support ongoing sales and marketing expansion, R&D investment into new product lines and build-out of manufacturing infrastructure. The investments originated from private equity funds in the U.S., Europe, Asia and the Middle East. Principal investors in the round include AGC Equity Partners and Axel Johnson, Inc., along with Government Investment Funds from Asia and the UAE.

Regulatory
Custom Spine announced that it has achieved ISO-13485 and received CE mark certification for all its current products sold in the U.S., including the ISSYS LP pedicle screw system.

Eden Spine received 510(k) clearance for its GIZA corpectomy device. The GIZA is an expandable titanium VBR with rotatable endplates that the company says "provide multiple angulation options by simple endplates rotation."

FH Orthopedics received 510(k) clearance for its PEEK fixation screws for the CoLS technique, which are designed for fixating the tendon graft to the femur and tibia during ACL and PCL reconstructive surgeries.

NLT SPINE received 510(k) clearance for its PROW FUSION Transforaminal-Lumbar Interbody Fusion device and delivery system. The company says that that the PROW FUSION offers a larger footprint than competitive devices, which is intended to provide "greater biomechanical stability and less subsidence postoperatively."

Product Introduction & Update
Spectrum Surgical Instruments Corporation launched a Large Orthopedic Pin Cutter. The pin cutters are stainless steel, fully-autoclavable and able to cut orthopedic pins up to 1/4" in diameter.

ThermoGenesis announced updates on clinical evaluations involving its Res-Q 60 BMC system, a point-of-care platform designed for the preparation of cell concentrates from bone marrow, in the treatment of critical limb ischemia and long bone fractures. The company said the results "demonstrate encouraging preliminary results with stem cell concentrates."

Intellectual Property
Interventional Spine announced that the United States Patent Office has issued U.S. Patent No. 8,105,382, entitled "Intervertebral Implant." This patent covers the company's expandable interbody fusion device, the Opticage.

Distribution and Licensing
BioRestorative Therapies entered into a License Agreement with Regenerative Sciences, LLC with respect to certain stem cell-related technology and clinical treatment procedures developed by RS. The company describes this treatment as an advanced stem cell injection procedure that may offer relief from lower back pain, buttock and leg pain or numbness and tingling in the legs or feet as a result of bulging and herniated discs.

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